Job Title: Regulatory Affairs Labeling Manager
Location: Trumbull, CT
Under the direction of the Sr. Director, Regulatory Special Projects, this position oversees all activities related to medical device and fertility & genomics labeling. Ensures requirements for labeling are met while maintaining compliance with regulatory and manufacturing regulations. In addition, the Manager, Labeling will represent the Regulatory Department as a labeling subject matter expert.
*Manage all aspects of the labeling group employees and responsibilities while maintaining a smooth and efficient operation.
*Demonstrate proficiency and provide leadership through the label process to meet company strategies and business objectives.
*Oversee the correct, complete, and compliant execution of product labeling and resolve problems and exceptions.
*Develop and maintain labeling procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.
*Understand and monitor label team participation in change control.
*Assure department activities comply with established SOPs, best practices, and GMPs.
*Identify and lead process for obtaining feedback from key stakeholders for continuous improvements to label process.
*Develop new processes which support speed, cost reductions, and process improvements. Optimize existing processes to maximize efficiency.
*Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement initiatives.
*Drive continuous improvements through observation, measurement and root cause analysis/resolution.
*Derive and present key performance indicators (KPIs)Monitor personnel performance via KPIs.
*Represent the labeling team as a subject matter expert, on company teams, and as a resource for other departments. Coordinate activities with other supply chain departments.
*Develop and maintain tools to manage label team workflow.
*Responsible for expense budget management related to the label group.
*Performs additional duties or assignments as directed by management.
*Bachelor's degree required, focus in Life Sciences preferred
*Minimum 5 years' direct work experience leading a team or department in a medical device manufacturing company
*Minimum 5 years' experience with Adobe Illustrator and InDesign (intermediate level)
*Experience implementing and using PRISYM 360 Medical Labeling and Enterprise Resource Planning (ERP) systems preferred
*Abilities and skills in management & organization
*Excellent verbal and written communication skills
*Must have strong collaboration skills, ability to interface with engineers, vendors and technicians
*Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases
Monroe Staffing Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, color, Religion, gender, disability, veteran status, sexual orientation, gender identity, national origin or other protected classification.